# FDA 483 - Catalent Ontario Limited - January 20, 2023

Source: https://www.keypedia.com/records/483/catalent-ontario-limited/bc9269fb-55da-4c79-9e30-2d8278f5d52e

> FDA 483 for Catalent Ontario Limited on January 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Catalent Ontario Limited
- Inspection Date: 2023-01-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Catalent Ontario Limited, a non-sterile bulk drug manufacturer in Windsor, identified one observation. The firm was cited for not storing drug product reserve samples in an immediate container-closure system that matches the marketed product. This indicates a potential issue with sample integrity and regulatory compliance.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/catalent-ontario-limited/f82ffd90-6386-4c44-a6df-7e2b4dd98453)
- [483 - 2023-01-20](https://www.keypedia.com/records/483/catalent-ontario-limited/649f7db1-3206-4d9c-a64e-d6f1407bc4b9)

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/catalent-ontario-limited/d28dfd20-1d16-4261-94e1-77497eb5150c

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1